Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohgah Elsheikh

ORCID ID

Contact details

Centre for Diabetes & Endocrinology
Melrose House
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
+44 (0)118 987 7131
mohgah.elsheikh@rbbh-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0199129935

Study information

Scientific title

Acronym

Study hypothesis

Does a low carbohydrate high protein diet enhance weight loss and improve symptoms in women with polycystic ovary syndrome (PCOS)? Assessment of the effects of the low carbohydrate diet on serum androgens and cardiovascular risk factors such as insulin sensitivity and plasma lipids.

Ethics approval

Not provided at time of registration

Study design

Randomised case-controlled prospective study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Polycystic ovarian syndrome (PCOS)

Intervention

Low Carbohydrate Diet vs Low Glycaemic Index Diet

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Weight, body composition, dietary compliance, menstrual cyclicity, ovulation, fasting glucose, insulin and lipids, hirsutism and serum androgens

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/07/2003

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

60 women with PCOS aged 18-45

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/07/2003

Recruitment end date

30/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Diabetes & Endocrinology
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Berkshire and Battle Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results published in http://www.endocrine-abstracts.org/ea/0015/ea0015P279.htm

Publication citations

Additional files

Editorial Notes